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Home / Healthcare Professional / Medicines supply chain and regulation / Adverse Drug Reaction Reporting

Adverse Drug Reaction Reporting

In order to report an Adverse Drug Reaction kindly click here. Submit electronically to the Medicines Authority postlicensing.medicinesauthority@gov.mt

Healthcare professionals are encouraged to report all ADRs to the Medicines Authority. Healthcare Professionals are hence requested to submit ADR reports using the ADR reporting form

HCPs may refer to the Adverse Drug Reaction Reporting & Pharmacovigilance Guidance Notes for Healthcare Professionals for further instruction on how to report ADRs.

The following are presentations on pharmacovigilance given by Medicines Authority staff members and are grouped here for your convenience and quick reference

1.  Pharmacovigilance Workshop II 20th June 2003 Medicines Regulation (2003)

2.  Safety of Patients: Diminishing Risk in Products and Practice (2004)

3.  Medicines Act: Pharmacovigilance and the Medical Profession  (2004)

4.  The Role of Healthcare Professionals in ADR reporting (2004)

5.  Pharmacovigilance & the New National Adverse Drug Reaction (ADR) Reporting System (2006)

6.  Pharmacovigilance & the New National Adverse Drug Reaction (ADR) Reporting System (2006)

7.  Summary of Product Characteristics & ADR Reporting Form (2006)

8.  Supporting the National Pharmacovigilance System (2011)

9.  How to report ADRs (2013)

10. Introduction to Post-Licensing (2017)

11. Post-Licensing Safety - Paxlovid Treatment and AE reporting (2022)